BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2499073 · Received March 21, 2012

    Report

    Report Number
    1056128-2012-00029
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 24, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) SO DEVICE TESTING COULD NOT BE PERFORMED. PAST COMPLAINT INVESTIGATIONS HAVE SHOWN THAT THIS TYPE OF DAMAGE TO THE BLADE IS TYPICALLY CAUSED BY THE SCALPEL COMING INTO CONTACT WITH A HARD OBJECT, SUCH AS A SURGICAL STAPLE OR CLIP, DURING USE. SSS'S INSTRUCTIONS FOR USE STATE: "AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS DURING INSTRUMENT ACTIVATION. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS DURING INSTRUMENT ACTIVATION MAY RESULT IN PREMATURE BLADE FAILURE, RESULTING IN GENERATOR SOLID TONE OR INSTRUMENT ERROR." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2011-00021 WHERE THE TIP OF THE DEVICE REMAINED IN THE PATIENT EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE BLADE OF THE ULTRASONIC SCALPEL BROKE OFF OF THE DEVICE. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1771792

    Patients

    Seq Age Sex Outcome Treatment
    1